An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06941376
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Relapsing Polychondritis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate (MTX) — DRUG
    Weekly methotrexate dose of 20 mg (oral or subcutaneous).
  • Azathioprine (AZA) — DRUG
    Azathioprine dose will be 2-3 mg/kg body weight per day.
  • Adalimumab — BIOLOGICAL
    Adalimumab dose will be 40 mg subcutaneously every 1-2 weeks
  • Infliximab — BIOLOGICAL
    Infliximab dose will be 5mg/kg at week 0 and week 2, and then every 4-8 weeks.
  • Tocilizumab — BIOLOGICAL
    Tocilizumab dose will be 162 mg subcutaneous injection every week or 4-8 mg/kg every 4 weeks

Study Details

Open label pragmatic two-stage non-randomized trial comparing the effectiveness of five different standard of care treatment options for patients with relapsing polychondritis (RP).

Key Dates

Start date
Aug 1, 2025
Status verified
Feb 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Azathioprine or Methotrexate
  • Experimental: Adalimumab, Infliximab, or Tocilizumab

Primary Outcome Measure

Efficacy of the study drugs for the treatment of relapsing polychondritis. [ Time Frame: 26 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Jessica Nguyen
[email protected]

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By research site
University of Pennsylvania· Philadelphia, PA

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